Spine Wave, Inc.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
57
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1960-2015Class IISpine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink Monopolar StimulMay 4, 2015
Z-2187-2013Class IIStaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog May 14, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K243816Testa TP Pivoting Spacer SystemJune 27, 2025
K251131Annex® 2 Adjacent Level SystemJune 6, 2025
K243514Salvo® Robotic Navigation InstrumentsApril 3, 2025
K240685Salvo® Spine SystemMay 6, 2024
K231275Exceed™ Biplanar Expandable Interbody SystemJuly 25, 2023
K222362Salvo® Spine SystemAugust 29, 2022
K202476Salvo® Spine SystemNovember 5, 2020
K192526Spine Wave Navigated InstrumentsOctober 10, 2019
K191045Salvo™ Spine SystemJuly 10, 2019
K182954Salvo™ Spine SystemDecember 12, 2018
K181596Spine Wave Navigated InstrumentsOctober 24, 2018
K181440Proficient® Posterior Cervical Spine SystemJuly 30, 2018
K172594Proficient® Posterior Cervical Spine SystemDecember 15, 2017
K173175Paramount Anterior Cervical Cage SystemNovember 1, 2017
K172175CapSure® PS SystemAugust 16, 2017
K163246Leva Anterior Expandable Spacer SystemApril 6, 2017
K162760Spine Wave Anterior Cervical Spine SystemFebruary 16, 2017
K162639Proficient™ Posterior Cervical Spine SystemFebruary 7, 2017
K161993Leva® Anterior Interbody SystemNovember 22, 2016
K153222Leva Spacer SystemApril 15, 2016